BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1865060 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10864
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY; (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. DISTAL CONDUCTOR HAD BLOOD/BODY FLUID. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS WERE DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID, OUTER INSULATION BREACHED CUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD, 4196, WAS REPLACED DUE TO DISLODGEMENT WHICH CAUSED DIAPHRAGMATIC STIMULATION. THE ATTEMPTED REPLACEMENT LEAD, MODEL 4194, WAS NOT ABLE TO BE PLACED SUCCESSFULLY DUE TO PATIENT ANATOMY. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD